XTalks

JANUARY 29, 2025

Related: Eli Lillys Kisunla (donanemab) Gets Full FDA Approval After Initial Rejection, Gears Up to Take on Leqembi Leqembi was first approved in 2023 as a monoclonal antibody targeting amyloid-beta protofibrils and plaques proteins that cause brain cell damage and cognitive decline in Alzheimers disease.

FDA Approval 66

FDA Approval Antibody Sales Protein 66

XTalks

APRIL 1, 2025

In hemophilia patients, inhibitors are antibodies that interfere with the effectiveness of clotting factor replacement therapies. Through RNA silencing, it targets the expression of antithrombin, a protein that inhibits blood clotting. The ATLAS-INH trial enrolled 77 patients with inhibitory antibodies to FVIII or FIX.

FDA Approval 59

FDA Approval RNA Clinical Trials Clinical Trials 59

pharmaphorum

JANUARY 13, 2022

Sanofi has joined a growing list of drugmakers going after alpha-synuclein targeting drugs for Parkinson’s disease, licensing a bispecific antibody from South Korea’s ABL Bio in a deal that could be worth more than $1 billion. An AbbVie antibody called ABBV-0805 successfully cleared a phase 1 trial but seems to have been shelved.

Antibody 98

Antibody Drugs Protein Licensing 98

pharmaphorum

DECEMBER 2, 2021

The drug – called UCB0599 – targets a protein called alpha synuclein that tends to get misfolded and accumulates into clumps in the brains of Parkinson’s patients, and is thought to damage neurons – somewhat analogous to amyloid and tau proteins in Alzheimer’s disease.

Antibody 111

Antibody Licensing Licensing Gene Therapy 111

Roots Analysis

SEPTEMBER 9, 2024

Over the years, pharmaceutical companies have shifted their priorities from traditional interventions towards more advanced pharmacological strategies, such as protein therapeutics. Further, $400 billion is the anticipated sales of protein-based therapeutics in 2023. The mRNA is then translated into to form functional proteins.

Protein 40

Protein Gene Production DNA 40

Pharmaceutical Technology

MARCH 10, 2023

Pharmaceutical and biotechnology industries widely use freeze-drying systems to protect vaccines, antibodies, antibiotics such as penicillin, blood plasma, proteins, enzymes, hormones, viruses, and bacteria from heat and minimise their biological activity.

Manufacturing 147

Manufacturing Production Containment Antibody 147

Pharmaceutical Technology

JUNE 6, 2023

Applying the drug’s phase transition success rate to remaining R&D costs and likelihood of approval (LoA) to sales related costs provides a risk-adjusted NPV model (rNPV). The company develops and discovers drugs that produce proteins or antibodies inside patient cells.

RNA 100

RNA Protein Antibody Vaccine 100

Pharmaceutical Technology

MARCH 23, 2023

Seagen specialises in developing antibody-drug conjugates (ADCs) which will complement Pfizer’s oncology portfolio. Seagen will maintain its operations in the Seattle area and will leverage Pfizer’s protein-engineering capabilities to develop next-generation biologics.

Licensing 147

Licensing Licensing Sales Trials 147

pharmaphorum

NOVEMBER 5, 2021

Novartis has chalked up another successful trial for its targeted factor B inhibitor iptacopan, an orally-active drug trying to challenge antibody-based therapies for diseases associated with the complement pathway. billion in peak annual sales if it gets approved for all its target indications.

Trials 105

Trials Protein Antibody FDA Approval 105

The Pharma Data

DECEMBER 14, 2020

Harbour BioMed (HBM) announced with Utrecht University on Monday that they have licensed their fully human SARS-CoV-2 neutralizing antibody, 47D11, and its program to AbbVie. AbbVie has initiated a Phase I clinical trial of the antibody, and it will conduct the initial clinical program in the U.S. before expanding it into Europe.

Antibody 52

Antibody Licensing Licensing In-Vitro 52

The Pharma Data

SEPTEMBER 17, 2020

The new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. The majority of current candidate vaccines aim to induce an antibody response against the spike protein. “As

Antibody 52

Antibody Vaccine Vaccination In-Vitro 52

pharmaphorum

AUGUST 19, 2020

The success of AbbVie’s Humira (adalimumab), which peaked at almost $20 billion in sales in 2018, demonstrates the potential of inflammatory diseases drugs to make mega-bucks.

Antibody 105

Antibody Drugs Protein Sales 105

pharmaphorum

JULY 13, 2021

The Danish drugmaker is paying $100 million upfront for rights to antibody drug PRX004, which is heading for phase 2 trials in cardiomyopathy associated with ATTR amyloidosis, a life-threatening disease affecting the heart and nervous system. According to analysts at GlobalData – sales are set to rocket to $3.5 billion by 2025.

Gene Silencing 98

Gene Silencing Sales Gene Editing Clinical Trials 98

pharmaphorum

JUNE 4, 2021

Bayer has agreed to buy Noria Therapeutics and its subsidiary PSMA Therapeutics, adding to its pipeline of radionuclide drugs for cancer as sales of its lead product in the category – Xofigo – continue to decline. . The technology behind the drug was licensed from Weill Cornell Medicine and Johns Hopkins University in the US.

Antibody 81

Antibody Licensing Licensing Protein 81

Pharmaceutical Technology

FEBRUARY 14, 2023

Adeno-associated virus vectors, alcohol dehydrogenase compositions, and antibody serum stabilisers are some of the accelerating innovation areas, where adoption has been steadily increasing. Among maturing innovation areas are anti-influenza antibody compositions and anti-interleukin 1, which are now well established in the industry.

Antibody 130

Antibody Hormones DNA Licensing 130

XTalks

AUGUST 14, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson announced that its bispecific antibody Talvey (talquetamab-tgvs) received US Food and Drug Administration (FDA) approval as a fifth-line treatment for adult patients with heavily pretreated multiple myeloma. Results were similar at the higher 0.8 mg/kg dose with an ORR of 73.6

FDA Approval 97

FDA Approval Antibody Immune Response Drugs 97

Delveinsight

JANUARY 12, 2021

Birinapant is a clinical-stage SMAC mimetic that degrades Inhibitors of Apoptosis Proteins (IAPs) by binding to them, ultimately leading to cell death in tumor cells. It is an IgM antibody targeting Death Receptor 5 (DR5), and IGM is hoping to test Birinapant with IGM-8444 for the treatment of solid cancers later this year.

Licensing 52

Licensing Licensing Antibody Gene Therapy 52

pharmaphorum

AUGUST 26, 2022

The US biotech claimed conditional marketing approval from the European Commission for Roctavian (valoctocogene roxaparvovec) as a treatment for adults with severe haemophilia A, who don’t have a history of developing the antibodies that inhibit the activity of blood-clotting protein Factor VIII.

Gene Therapy 111

Gene Therapy Gene Antibody Marketing 111

XTalks

JANUARY 4, 2024

The adeno-associated viral (AAV) vector-based gene therapy received approval in Canada for the treatment of adults aged 18 years or older with moderately-severe to severe hemophilia B who are negative for neutralizing antibodies to variant AAV serotype Rh74, Pfizer Canada revealed in its announcement of the approval. Priced at $3.5

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

pharmaphorum

OCTOBER 21, 2022

The acquisition of DJS Antibodies, a privately-held UK-based biotechnology company dedicated to discovering and developing antibody medicines that target difficult-to-drug disease-causing proteins – such as G protein-coupled receptors (GPCRs) – will extend AbbVie’s present discovery research capabilities, through DJS’ proprietary HEPTAD platform.

Antibody 59

Antibody Protein Research Medicine 59

pharmaphorum

MARCH 9, 2022

Sanofi and Sobi’s haemophilia partnership has been under competitive pressure from new therapies like Roche’s antibody Hemlibra, so the two companies are hoping a new long-acting drug candidate can revitalise the franchise. The half life of the new drug – one of the main draws for Sanofi’s $11.6

Protein 98

Protein Gene Therapy Sales Regulation 98

XTalks

FEBRUARY 26, 2024

Xolair is a monoclonal antibody that binds to IgE, a type of antibody in the body that triggers allergic reactions, to block it from binding to its receptors. billion in sales last year. Xolair is the first medication approved by the FDA to reduce allergic reactions to more than one type of food after accidental exposure.

Allergies 100

Allergies FDA Approval Drugs Protein 100

XTalks

FEBRUARY 5, 2024

The top 40 best-selling oncology drugs in 2023, informed by 2022 sales statistics, mark significant milestones in cancer treatment and research. Read on to learn more about the top 40 best-selling oncology drugs in 2023, based on 2022 sales data. Price of Revlimid: A supply of 28 oral 2.5 mg capsules is $24,576.

FDA Approval 101

FDA Approval Drugs Sales Development 101

Delveinsight

OCTOBER 1, 2021

This disease is associated with antibodies directed against the acetylcholine receptor, muscle-specific kinase (MUSK), lipoprotein-related protein 4 (LRP4), or agrin in the postsynaptic membrane at the neuromuscular junction. The latter are Anti-Acetylcholine Receptor (AChR) antibody-positive. Soliris (Eculizumab).

Marketing 85

Marketing Antibody Drugs Sales 85

pharmaphorum

AUGUST 27, 2021

Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients with certain types of lymphoma. Both Yescarta and Kymriah are already on sales in the EU, while Breyanzi is under regulatory review.

Antibody 72

Antibody Sales Protein Marketing 72

The Pharma Data

JANUARY 12, 2021

million additional doses of the casirivimab and imdevimab antibody cocktail, bringing total potential U.S. Under the new agreement, the government will purchase all finished doses of the casirivimab and imdevimab antibody cocktail delivered by June 30, 2021 , up to 1.25 TARRYTOWN, N.Y. , 12, 2021 /PRNewswire/ — . million doses.

Antibody 52

Antibody Production Manufacturing Clinical Trials 52

Pharmaceutical Technology

DECEMBER 9, 2022

The move is particularly timely given the significant growth expected in global sales of cell and gene therapies. Beyond our expertise in small molecules, we have built a solid reputation with biopharmaceutical companies for the characterisation and analysis of monoclonal antibodies, therapeutic proteins and biosimilars.

Development 130

Development Production Manufacturing Vaccine 130

pharmaphorum

JUNE 9, 2022

mRNA-1273.214 stimulated almost twice the neutralising antibody levels against the Omicron strain than Spikevax , with a significantly higher response also seen against other variants of concern, one month after administration, according to the company. It has predicted sales of COVID-19 vaccines will be around $21 billion this year.

Vaccine 105

Vaccine Vaccination Containment Clinical Trials 105

pharmaphorum

FEBRUARY 9, 2022

Closely related to this is the fact that global spending on oncology drugs reached $164 billion in 2020, with drug sales growing at a compound annual growth rate of 14.3% While therapeutic cancer vaccines are able to help the body identify particular proteins expressed by cancer cells and then to instigate an immune response.

Vaccine 134

Vaccine Vaccination Clinical Trials Clinical Trials 134

pharmaphorum

DECEMBER 18, 2020

Originally approved in 2011 as an IV therapy for adults with SLE, a debilitating autoimmune disease, GSK got a green light for the subcutaneous formulation in 2017 and last year extended the label of the antibody to include paediatric patients aged over five.

FDA Approval 99

FDA Approval Contract Manufacturing Sales Trials 99

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. billion in pharmaceutical sales from 2021. In contrast, several drugs experienced sale declines, such as Remicade (infliximab), an old immunology medication that continues to decline due to the rise of biosimilars since 2016.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

pharmaphorum

MARCH 31, 2021

The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is found much more abundantly in solid tumours. billion or more in peak sales. “We believe this technology has the potential to transform many patients’ lives,” she added. .

Licensing 98

Licensing Licensing Gene Therapy Sales 98

pharmaphorum

NOVEMBER 16, 2021

Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. In another 14-day trial involving men and women, MK-0616 reduced LDL cholesterol by around 65% from baseline when it was added to background therapy with statins.

Trials 98

Trials Drugs Sales Clinical Trials 98

pharmaphorum

SEPTEMBER 2, 2020

The drug, JTX-1811, is a monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. . When JTX-1811 binds to CCR8, it targets TITR cells for depletion by an enhanced antibody-dependent cellular cytotoxicity mechanism. .

Licensing 71

Licensing Licensing Antibody Immune Response 71

XTalks

JUNE 30, 2023

Hemophilia A is a rare genetic bleeding disorder that is caused by a mutation in the gene that encodes the key blood clotting protein factor VIII (FVIII). Severe hemophilia A is usually treated with FVIII replacement therapy or an antibody-based drug to improve the ability of blood to clot and reduce the likelihood of bleeding.

Gene Therapy 98

Gene Therapy Gene FDA Approval Antibody 98

The Pharma Data

AUGUST 18, 2020

REGN-COV2 is Regeneron’s two-antibody combination currently in late-stage clinical trials for the treatment and prevention of COVID-19 infection. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and around the world.

Antibody 52

Antibody Clinical Trials Clinical Trials Manufacturing 52

The Pharma Data

DECEMBER 29, 2020

First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. NASDAQ: REGN) today announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. futility analysis).

Antibody 52

Antibody Trials Production Clinical Trials 52